Category Archives: FDA media releases

On February 4th, 2009 the FDA announced an ongoing safety review of Xigris (Drotrecogin alfa [activated]). An introduction from Wikipedia: Drotrecogin alfa (activated) (Xigris, marketed by Eli Lilly and Company) is a recombinant form of human activated protein C ( rhAPC) that has anti-thrombotic, anti-inflammatory, and profibrinolytic properties. Drotrecogin alpha (activated) belongs to the class…

Pharmamotion has now a new page containing updates on clopidogrel PPI interactions. The FDA issued today an early communication about an ongoing safety review of the antiplatelet agent clopidogrel bisulfate (Plavix). The backgroung to this is the recent evidence of: A decreased response to clopidogrel in some patients. Since clopidogrel is a prodrug, genetic polymorphisms…

FDA updated yesterday ( January 8, 2009) information related to their review of the ENHANCE trial: On January 25, 2008, FDA announced that it would be reviewing data from the ENHANCE trial (Effect of Combination Ezetimibe and High-Dose Simvastatin vs. Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia). (http://www.fda.gov/cder/drug/early_comm/ezetimibe_simvastatin.htm). Preliminary results from this…… Continue Reading

FDA press relase about the approval of imatinib (Gleevec) for the treatment of GIST tumors: FOR IMMEDIATE RELEASE December 19, 2008 FDA Approves Gleevec to Prevent Recurrence of Rare Gastrointestinal Cancer The U.S. Food and Drug Administration today approved Gleevec (imatinib mesylate) for a new indication –… Continue Reading

From the FDA’s newsroom: FDA Approves Drug that Boosts Stem Cell Yield for Bone Marrow Transplants The U.S. Food and Drug Administration today approved Mozobil (plerixafor), a drug that helps increase the number of blood stem cells for bone marrow transplantation in patients with certain forms of blood cancer. Mozobil is intended to be used…… Continue Reading

The FDA will require manufacturers of antiepileptic drugs (AEDs) to inclued a warning about the increased risk of suicidal thoughts and behaviours when using these drugs. This is a transcript of the original press release dated Dec. 16, 2008: FDA Requires Warnings about Risk of Suicidal Thoughts and Behavior for Antiepileptic Medications The U.S. Food…… Continue Reading

From JournalWatch: FDA Panel Votes to Ban Two Drugs for Asthma An advisory panel to the FDA voted Thursday to ban two long-acting beta agonists, Serevent (salmeterol) and Foradil (formoterol), for treating asthma in adults and children. When taken without an inhaled corticosteroid, these drugs can… Continue Reading

From FDA’s patient safety news website: Statin Use and the Risk of ALS A recent FDA analysis provides new evidence that using statins does not increase the risk of amyotrophic lateral sclerosis (ALS), a neurodegenerative disease also known “Lou Gehrig’s Disease.” Cholesterol-lowering statins such as Lipitor (atorvastatin calcium) and Zocor (simvastatin) have been shown to…… Continue Reading

From FDA Patient Safety News: “Drug Name Confusion: Ephedrine and Epinephrine The Institute for Safe Medication Practices (ISMP) is warning again about the possibility of mix-ups between ephedrine and epinephrine. Not only do the names of these drugs look and sound similar, but since they’re both used as vasopressors and vasoconstrictors, they’re often stored next…… Continue Reading

FDA news release about the approval of pentadol to alleviate moderate to severe Pain: The U.S. Food and Drug Administration has approved Tapentadol hydrochloride, an immediate-release oral tablet for the relief of moderate to severe acute pain. Tapentadol is a centrally-acting synthetic analgesic that is available in doses of 50 mg, 75 mg, or 100…